GL Biochem (Shanghai) Ltd.
Premium PartnerIs this your company? Claim this profile
Drug Product
Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
GL Biochem (Shanghai) Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:China
Founded:1992
Employees:464
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Regulatory Approvals
Drug Approval N0RF4J
EMA · #APR-01DJLMTW · 2022-02-01
Drug Approval WFLO58
FDA · #APR-QI9VC9FC · 2018-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-V0JAOEJO
Issued: 2020-06-16
Expires: 2025-06-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EF4HOZ1U
Issued: 2020-09-12
Expires: 2025-07-06
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-PKOK3CXO
Issued: 2020-06-07
Expires: 2025-06-17
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-20HLPZYF
Issued: 2020-02-24
Expires: 2025-11-11
Loading CDMO intelligence...
Key facts about GL Biochem (Shanghai) Ltd.
- GL Biochem (Shanghai) Ltd. is headquartered in China.
- GL Biochem (Shanghai) Ltd. was founded in 1992.
- GL Biochem (Shanghai) Ltd. has 464 employees.
- GL Biochem (Shanghai) Ltd.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
Find CDMOs like GL Biochem (Shanghai) Ltd.
Directory pages this company appears in, each with the full list of matching manufacturers.